The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 6
- 主要终点
- Number of patients with a modified Rankin Score (mRS) below or equal to 2
研究概览
简要总结
Intracranial bifurcation aneurysms are commonly repaired with surgical and with endovascular techniques. Wide-necked bifurcation aneurysms (WNBA) are a difficult subset of aneurysms to successfully repair endovascularly, and a number of treatment adjuncts have been designed. One particularly promising innovation is the WEB (Woven EndoBridge), which permits placement of an intra-saccular flow diverting mesh across the aneurysm neck, but which does not require anti-platelet agent therapy. Currently, which treatment option leads to the best outcome for patients with WNBA remains unknown. There is a need to offer treatment with the WEB within the context of a randomized care trial, to patients currently presenting with aneurysms thought to be suitable for the WEB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with an intracranial aneurysm in whom WEB is considered an appropriate therapeutic option by the participating clinician
- •aneurysm of maximum diameter of 4-11 mm
- •may include (but are not restricted to) saccular bifurcation aneurysms of the middle cerebral artery, basilar bifurcation, carotid terminus, or anterior communicating artery aneurysms
- •Recurring, persistent aneurysm after previous treatment can be included so long as the treating physician judges the aneurysm morphology to be appropriate.
- •Ruptured aneurysms with WFNS ≤ 3
排除标准
- •Absolute contraindication to surgery, endovascular treatment or anesthesia
- •Patients unable to give informed consent
- •diameter of the aneurysm ≤ 4 mm but ≥ 11 mm
- •Ruptured aneurysms with WFNS 4 or 5
结局指标
主要结局
Number of patients with a modified Rankin Score (mRS) below or equal to 2
时间窗: 1 year from procedure
mRS ≤2 from evaluation (questionnaire) at follow-up visits throughout study. Grading score is to be assessed as such: Grade 0 No symptoms at all. Grade 1 No significant disability despite symptoms; able to carry out all usual duties and activities Grade 2 Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance Grade 3 Moderate disability; requiring some help, but able to walk without assistance Grade 4 Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance Grade 5 Severe disability; bedridden, incontinent and requiring constant nursing care and attention Grade 6 Dead
Number of participants with imaging showing that index aneurysm has reached complete or near occlusion
时间窗: 1 year from procedure
complete or near complete occlusion of the aneurysm
次要结局
- Number of aneurysm re-occurrences, (re-)rupture, or incomplete occlusion based on angiographic imaging(12 +/- 2 months)
- Hospitalization time(up to first post-procedure visit (around 1 month))
- Number of peri-operative complications(≥5 days)
- Number of participants with an interim modified Rankin Scale (mRS) below or equal to 2(within 1 week post-procedure, 1-3 months, and 12 months post-treatment)
- Number of successful deployment of WEB device, coils or successful microsurgical, clipping, along with judgement of patency of parent arteries using imaging (depending on treatment received)(within 1 hour from procedure)
- Number of incidences of successful or unsuccesful patency of parent arteries using imaging(within 1 hour from procedure)
- Incidence of discharge destination by type(up to first post-procedure visit (around 1 month))
- Number of index aneurysms necessitating or having received retreatment due to re-occurence(Within 12 +/- 2 months)
- Number of participants with stroke, neurological symptom or sign(within 12 +/- 2 months)